Self-Cath 50455 / 418Recalls & reported problems
Coloplast A/S · No description. · Class 2
All models of Self-Cath (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708932576383), received between Jan 7, 2016 and Sep 26, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
- Physical Property Issue1
- Scratched Material1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Laceration(s)1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 26, 2018Break
ACCORDING TO THE AVAILABLE INFORMATION, THE SELF-CATH TIP BROKE. THE PATIENT IS KEEPING THE CATH INSERTED OVERNIGHT AND THEN IRRIGATING WITH IT IN THE MORNING. THE ¾ INCHES OF THE CATHETER TIP FELL OFF/ BROKE INSIDE THE USER. SURGERY IS SCHEDULED TO REMOVE FROM BLADDER.
Patient problems: No Code Available
MAUDE report 7910727 ↗InjuryJan 7, 2016Physical Property Issue; Scratched Material
ACCORDING TO THE INFORMATION RECEIVED, END USER SAYS THE HOLES DO NOT APPEAR TO BE PUNCHED CORRECTLY (NOT SMOOTH AROUND HOLES). SAYS THE AREA AROUND THE HOLES ARE "BULGED UP" LEAVING THE EYELETS ROUGH RATHER THAN SMOOTH. SAYS HE HAS BEEN GETTING CUT BY THE CATHETERS AS A RESULT. HE HAS HAD BLEEDING FOR A DAY, AND THEN IT SUBSIDES.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)
MAUDE report 5352462 ↗
Other CATHETER, STRAIGHT devices
- Magic3 Go Male Catheter with SureGrip 53814GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall490 reports
- Magic3 Go Male Coude Catheter with SureGrip 50814GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall3 deaths416 reports
- Magic3 Go™ Intermittent Urinary Catheter 51814C. R. Bard, Inc. · CATHETER, STRAIGHT1 recall327 reports
- Magic3 Go Male Coude Catheter with SureGrip 50816GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall239 reports
- Magic3 Go Male Catheter with SureGrip 53816GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall164 reports
- Magic3 Go Male Catheter with SureGrip 53812GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall120 reports
- Magic3 Go™ Intermittent Urinary Catheter 51812C. R. Bard, Inc. · CATHETER, STRAIGHT1 recall109 reports
- CURE CATHETER HM14Convatec, Purchasing Department · Catheter, Straight154 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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